510(k) K223873 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
Boppli Infant Blood Pressure Monitor
| Applicant | Pyrames, Inc., Cupertino CA, US |
| Decision | Substantially Equivalent, Sep 29, 2023 |
| Received | Dec 23, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223873
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 2, 2025 | PYRAMES INC Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007 Open, Classified |
DXN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.